510(k) Report

Devices descending from K061000

11 later devices reach Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath…Cook Vascular, Inc.20140—
+1K141148Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL…Cook Vascular, Inc.20142—
+1K140047Lexiconture Mechanical Dilator Sheath SetSpectranetics Corp.20147—
+2K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.20260—
+2K211679Xtractor deviceXcardia Innovation, Ltd.20220—
+2K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc.20145—
+2K141131Tightrail MiniSpectranetics, Inc.20146—
+3K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc.20162—
+3K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc.20153—
+4K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc.20221—
+5K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…Spectranetics, Inc.20220—